Bioequivalence and Bioavailability Forum

Dear Kotu!

❝ Please clarify regulatory acceptance by US-FDA for a study conducted for Europe region.

Zero. See the BE GL, Section 4.1.2:

For Article 10(1) and 10(3) marketing authorisation applications reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted in the Union on the basis of a complete dossier in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, as amended.

❝ The reference product is manufatcured in the same facility for both US & Europe and being marketed by the same brand name in both the regulatory regions.

Do you have a proof for your assumption? EMA would require an official statement by the innovator supporting your claim that the US-RLD ≡ an authorised reference in the EU. You will never get it for obvious reasons. Furthermore, are you sure that the claimed indications, recommended posology, etc. are identical (i.e., the US-label = the European SmPC)?